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Safety of Cardiac Pacemakers in 3 Tesla MRI

NCT ID: NCT00356330

Last Updated: 2007-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Brief Summary

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To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.

Detailed Description

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Recently, a shift could be observed from cardiac pacemakers being an absolute contraindication to being a relative contraindication for MR imaging at 1.5 Tesla, depending on a patient-per-patient risk-benefit-evaluation, which includes an urgent clinical need for MR imaging (other imaging modalities non-conclusive) and co-morbidities (especially cardiac co-morbidities). At the same time, MR imaging at 3 Tesla is evolving from a research application only to an important imaging modality today.

Using the improved signal-to-noise-ratio, high field MR-Systems with a field strength of 3 Tesla offer a variety of diagnostic advantages to 1.5 Tesla systems. These advantages lead to a higher sensitivity and specificity in diagnosing, foremost neurological, disorders.

In this study, we evaluate the safety of MR imaging of the brain in patients with cardiac pacemakers at 3T.

Conditions

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Heart Diseases

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Urgent need for an MRI examination
* Stable pacemaker physical parameters

* Battery voltage \> 2.7 V
* Battery impedance \< 2000 Ohm
* Battery estimated remaining lifetime \> 6 months
* Lead impedances 200-2000 Ohm
* Stable pacing parameters

* Pacing capture threshold \<2.5V at a pulse duration of 0.4ms
* Sensing \> 5mV
* Minimum 3 months since pacemaker and lead implantation

Exclusion Criteria

* History of ventricular tachycardia (VT) or ventricular fibrillation
* Unstable angina
* Myocardial infarction within the previous 3 months
* Cardiothoracic surgery within the previous 3 months
* Presence of an abdominal pacemaker with lead length \> 70 cm
* Presence of MRI incompatible bioimplants or other MRI incompatible materials
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Principal Investigators

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Torsten Sommer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bonn, Department of Radiology

Locations

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University of Bonn, Department of Radiology

Bonn, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Torsten Sommer, MD

Role: CONTACT

[email protected]
+49-163-6113875

Claas P Naehle, MD

Role: CONTACT

[email protected]
+49-178-4001619

Facility Contacts

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Torsten Sommer, MD

Role: primary

[email protected]
+49-163-7113875

Claas P Naehle, MD

Role: backup

[email protected]
+49-178-4001619

Other Identifiers

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116/06

Identifier Type: -

Identifier Source: org_study_id